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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name container, i.v.
510(k) Number K832254
Device Name BAXA ADDISEAL
Applicant
BAXA CORP., SUB. OF COOK GROUP, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
BAXA CORP., SUB. OF COOK GROUP, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number880.5025
Classification Product Code
KPE  
Date Received07/11/1983
Decision Date 07/26/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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